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IRCT20251026067770N2 IRCT 2025-11-27 Islamic Azad University Evaluating the Impact of a Mindfulness Training Program on Anxiety and Quality of Life in Patients with Kidney Cancer Comparison of the Effectiveness of Mindfulness-Based Cognitive Therapy and Usual Care in Reducing Anxiety and Improving Quality of Life in Patients with Kidney Cancer 2025-12-01 anticipated 35 Complete https://irct.ir/trial/87707 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization will be performed using the website https://www.randomization.com. The random allocation list will be generated by a statistician who is not involved in the implementation or assessment of the study. Variable block randomization with block sizes of 4 and 6 will be used to maintain balance in the number of participants between the Mindfulness-Based Cognitive Therapy (MBCT) group and the no-intervention control group. Allocation codes will be placed in opaque, sealed, sequentially numbered envelopes to ensure concealment of the random sequence until the moment of assignment. Upon each participant’s entry into the study, the envelope corresponding to their order of enrollment will be opened by the registration officer, and the participant will be assigned to the appropriate group, Blinding description: This study was designed as a single-blind trial with participant and outcome-assessor blinding. Participants were not informed of their allocation to either the Mindfulness-Based Cognitive Therapy (MBCT) group or the control group, and they were not told which intervention condition they would receive. Psychological outcomes (including anxiety and quality of life) were assessed by evaluators who were blinded to the randomization sequence and group assignments. In addition, statistical analyses were conducted by a data analyst who received group labels in coded and anonymized form and was therefore unaware of the intervention status of each participant. Only the therapist was aware of group allocations in order to deliver the intervention. Participants, outcome assessors, and the data analyst had no direct knowledge of the randomization process or its results. N/A Kidney cancer. Intervention 1: Intervention group: The Mindfulness-Based Cognitive Therapy (MBCT) program will be delivered in 8 weekly group sessions, each lasting 120 minutes. The intervention follows the standard MBCT protocol developed by Segal, Williams, and Teasdale. Each session includes mindfulness practices (such as mindful breathing, body scan, and attention to thoughts and emotions), cognitive-behavioral exercises targeting maladaptive thinking patterns, homework assignments, and group discussions. Participants will be trained to increase awareness of their automatic thoughts, reduce rumination, and cultivate nonjudgmental attention to present-moment experiences. They will receive audio recordings and weekly home practice instructions (approximately 30 minutes per day). The sessions will be conducted by a licensed clinical psychologist experienced in delivering MBCT. Intervention 2: Control group: The control group will not receive any intervention during the study period. However, to ensure ethical considerations, participants in the control group will be offered the Mindfulness-Based Cognitive Therapy (MBCT) program after the completion of the study and the post-test assessments. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The final policy regarding sharing of individual participant data (IPD) has not yet been determined. Anonymized data may potentially be shared in the future upon reasonable request from qualified researchers and subject to ethics approval, but this has not been finalized.
public Fatemeh Bardideh
No. 56, After Boostan, 11 South Khayyam, Khayyam Boulevard
Mashhad Iran (Islamic Republic of) 9174658155 +98 51 3761 8121 Fbardideh@yahoo.com Islamic Azad University scientific Hossein Salimi Bajestani
Central Campus, Allameh Tabataba'i University, Dehkadeh Square, Olympic Village
Tehran Iran (Islamic Republic of) 1489684511 +98 21 4829 0000 H.salimi.b@gmail.com Allameh Tabataba'i University Iran (Islamic Republic of) Receiving a confirmed diagnosis of kidney cancer from a specialist physician Obtaining a high score on the Spielberger State-Trait Anxiety Inventory (STAI) Providing informed consent to participate in the study Being between 40 and 60 years of age At least 6 months having passed since the initial cancer diagnosis, with the cancer still ongoing (i.e., not in complete remission). 40 years 60 years Both Recovery from / remission of kidney cancer Lack of willingness to continue participation in the study Use of any psychiatric medication in the past three months, or participation in psychotherapy sessions within the past six months Presence of any personality disorder or transient psychotic features, as assessed by the Minnesota Multiphasic Personality Inventory (MMPI) Uncontrolled pain at the time of entering the intervention. C64 Malignant neoplasm of kidney, except renal pelvis Treatment - Other Treatment - Other Intervention group: The Mindfulness-Based Cognitive Therapy (MBCT) program will be delivered in 8 weekly group sessions, each lasting 120 minutes. The intervention follows the standard MBCT protocol developed by Segal, Williams, and Teasdale. Each session includes mindfulness practices (such as mindful breathing, body scan, and attention to thoughts and emotions), cognitive-behavioral exercises targeting maladaptive thinking patterns, homework assignments, and group discussions. Participants will be trained to increase awareness of their automatic thoughts, reduce rumination, and cultivate nonjudgmental attention to present-moment experiences. They will receive audio recordings and weekly home practice instructions (approximately 30 minutes per day). The sessions will be conducted by a licensed clinical psychologist experienced in delivering MBCT. Control group: The control group will not receive any intervention during the study period. However, to ensure ethical considerations, participants in the control group will be offered the Mindfulness-Based Cognitive Therapy (MBCT) program after the completion of the study and the post-test assessments. Anxiety score on the State–Trait Anxiety Inventory (STAI) developed by Spielberger. Timepoint: At the beginning of the study (before the intervention) and after the end of the intervention. Method of measurement: Spielberger State-Trait Anxiety Inventory. Quality of life score on the World Health Organization Quality of Life (WHOQOL) questionnaire. Timepoint: At the beginning of the study (before the intervention) and after the end of the intervention. Method of measurement: World Health Organization Quality of Life Questionnaire. Islamic Azad University Approved 2025-01-27 Medical Research Ethics Committee, Faculty of Medicine, Islamic Azad University, North Tehran Branch 5th Floor, Shahid Fakhrizadeh Research and Laboratory Building, Islamic Azad University, North Tehran Branch, Vafadar Boulevard, Shahid Sadooghi Street, Hakimiyeh Exit, Shahid Babayi Expressway (West to East) Tehran Tehran Iran (Islamic Republic of)